Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00193973




Registration number
NCT00193973
Ethics application status
Date submitted
13/09/2005
Date registered
19/09/2005
Date last updated
17/02/2017

Titles & IDs
Public title
Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma
Scientific title
A Phase 2 Study of Idarubicin Based Combined Modality Therapy in Primary Central Nervous System Lymphoma
Secondary ID [1] 0 0
ALLG LY4
Secondary ID [2] 0 0
TROG 01.02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Central Nervous System Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-C
Treatment: Other - Radiation Therapy

Active comparator: 1 -


Treatment: Drugs: Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-C
Idarubicin 15mg/m2 days 1, 22. Filgrastim 5mcg/kg until neutrophil recovery days 2, 23. Methotrexate 1g/m2 days 15, 36 and 50.

Treatment: Other: Radiation Therapy
Whole brain Irradiation, 30Gy in 20 fractions over 4 weeks
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To estimate the median and 2 year overall survival.
Timepoint [1] 0 0
Estimate of survival at 2 years and at 5 years.
Secondary outcome [1] 0 0
Assess acute toxicity.
Timepoint [1] 0 0
Interim actute toxicity analyses will be performed at accrual points: 5, 10, 15, 20 and 25 patients.
Secondary outcome [2] 0 0
Assess functional indices of living in patients with PCNSL.
Timepoint [2] 0 0
Analysis will be at 5 years.
Secondary outcome [3] 0 0
To estimate the risk of late neurotoxicity relative to results achieved in TROG 92.01.
Timepoint [3] 0 0
Analysis at 3 years.

Eligibility
Key inclusion criteria
* Histologically proven primary CNS lymphoma.
* Absence of disease outside the CNS.
* ECOG performance status 0-3
* Negative HIV status.
* Peripheral blood counts with granulocytes >1.5 x 109L and platelets > 100 x 109L. Serum creatinine <150mmol/L. Serum bilirubin <1.5 times and AST <2 times upper limit of normal.
* Age >18 and <=70 years.
* Patients must give written informed consent.
* Corticosteroids prior to histological diagnosis are allowed.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous history of malignancy (other than non-melanomatous skin carcinoma, or carcinoma in situ of cervix completely excised).
* Patients who are pregnant or lactating.
* NYHA (New York State Heart Association classification) cardiac failure grade 3
* Macroscopic spinal thecal or spinal cord disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2013
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [3] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 0 0
Westmead Hospital - Wentworthville
Recruitment hospital [5] 0 0
Illawarra Cancer Care Centre - Wollongong
Recruitment hospital [6] 0 0
Royal Brisbane Hospital - Herston
Recruitment hospital [7] 0 0
Mater QRI - South Brisbane
Recruitment hospital [8] 0 0
Premion - Tugun - Tugun
Recruitment hospital [9] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [10] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [11] 0 0
Andrew Love Cancer Centre, Geelong Hospital - Geelong
Recruitment hospital [12] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [13] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2298 - Newcastle
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2145 - Wentworthville
Recruitment postcode(s) [5] 0 0
- Wollongong
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment postcode(s) [8] 0 0
4224 - Tugun
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [10] 0 0
5000 - Adelaide
Recruitment postcode(s) [11] 0 0
3220 - Geelong
Recruitment postcode(s) [12] 0 0
8006 - Melbourne
Recruitment postcode(s) [13] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australasian Leukaemia and Lymphoma Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter O'Brien, FRANZCR
Address 0 0
Newcastle Mater Misericordiae Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00193973